Safety device for drug delivery devices and containers

ABSTRACT

A drug administration safety device having a label configured to be attached to a drug container such as a syringe or IV bag, an adhesive on the back face of the label, and a backing or substrate for holding the label and protecting the adhesive prior to the application of the label to the drug container. In one embodiment, the label includes a first drug name section in a first orientation, a second drug name section in a second orientation, a third drug name section in a third orientation, a drug concentration section, a variable information section, and a gradiation viewing section. The first orientation, second orientation, and third orientation are different from each other to enable a user to readily see the drug name regardless of the position and orientation of the drug container.

PRIORITY CLAIM

This continuation patent application claims priority to and the benefitof U.S. patent application Ser. No. 12/123,301, filed May 19, 2008,which is a non-provisional patent application which claims priority toand the benefit of U.S. patent application No. 60/991,994, filed Dec. 3,2007, the entire contents of which are incorporated herein by reference.

COPYRIGHT NOTICE

A portion of the disclosure of this patent document contains or maycontain material which is subject to copyright protection. The copyrightowner has no objection to the photocopy reproduction by anyone of thepatent document or the patent disclosure in exactly the form it appearsin the Patent and Trademark Office patent file or records, but otherwisereserves all copyright rights whatsoever.

BACKGROUND

According to the Institute of Medicine (IOM), medication orpharmaceutical errors harm at least 1.5 million people every year in theUnited States alone. The IOM further reports that at least onemedication error per patient per day has occured in each hospital in theUnited States during the 2006-2007 timeframe.

More specifically, if a drug is not promptly administered and deliveredto a patient to correct a deviation from normal physiologicalparameters, a series of abnormal functions by the patient's body mayresult. For example, a patient under anesthesia during surgery mayrequire prompt intervention to maintain certain systems and functions ofthe patient's body such as blood pressure, fluid balance and the like.An anesthesiologist or certified registered nurse anesthetist often mustquickly use drugs at various different concentrations to counteract thestress on these systems and functions due to the surgery.

To administer and deliver a drug quickly to a patient, health careproviders use routes of administration such as intravenous (IV) accessto deliver drugs in liquid form to the patient. Many drugs areformulated to be administered by pump, IV container or by syringe andare pre-filled into these drug devices or containers for administration.A drug in the device or container is also formulated at a predeterminedconcentration to enable a suitable dose of the drug to be delivered inan appropriate volume, thereby eliminating the need for recalculatingthe dose or diluting the drug prior to its administration or betweenadministrations. When using pre-filled syringes, for example, eachcontaining a predetermined concentration of the drug for quick deliveryof a drug to a patient, a health care provider (such as ananesthesiologist) must have readily available multiple similar syringesfor multiple drugs and multiple similar syringes of differentconcentrations of the same drug. This may increase the likelihood ofmedication errors.

Certain steps have been taken to attempt to minimize errors in theadministration of medications. For example, the American Society forTesting and Materials (ASTM) has established color schemes for labels todistinguish drug classes from one another. However, errors inadministration of such drugs and medication to patients continue topersist. There is therefore a need for improved devices which furtherminimize drug or medication administration errors.

SUMMARY

The present disclosure provides various embodiments for a drugadministration safety device which includes a label configured to beattached to a drug container such as a syringe or IV bag, an adhesive onthe back face of the label, and a backing or substrate for holding thelabel and protecting the adhesive prior to the application of the labelto the drug container. In various embodiments, the label includesmultiple sections. In one embodiment, the label includes a first drugname section in a first orientation, a second drug name section in asecond orientation, a third drug name section in a third orientation, adrug concentration section, a variable information section, and agraduation viewing section. The first orientation, second orientation,and third orientation are different from each other to enable a user toreadily see (in an upright readable position) the drug name regardlessof the position and orientation of the drug container. In a furtherembodiment, the label includes a fourth drug name section in a fourthorientation, which is also different from the first, second and thirdorientations. The present disclosure also provides a drug containerhaving the label attached to the drug container by the adhesive.

In further embodiments, each label for a specific drug concentrationsection includes one or more specific shapes associated with suchconcentration. Thus, different labels for different concentrations ofthe same drug will have different shapes in the respective drugconcentration sections of the different labels.

The present disclosure also provides various embodiments for developingschemes for differentiating labels for different concentrations of thesame drug. In an embodiment, each of a sequence of different shapes isassociated with each of the different concentrations of the same drug.The shape corresponding to the concentration to be included on a labelfor that drug is used in the drug concentration sections of the labelfor that drug.

An advantage of the present disclosure includes providing a drugadministration safety device that reduces the risk of errors inadministration of medication by presenting certain information in thelabel in various orientations to enable the user to readily read orrecognize the information regardless of the position of the drugcontainer.

Another advantage of the present disclosure includes providing a drugadministration safety device that reduces errors in administration ofmedication by distinguishing similar drug containers for the same drugthrough the use of different visual cues such as different shapesassociated with different concentrations of the drug.

A further advantage of the present disclosure is the creation of asystematic way of distinguishing different doses of the same drugthrough a sequence of different shapes associated with a sequence ofincreased doses of the drug and using the same or similar sequence ofshapes associated with a sequence of increased doses of another drug.

Additional features and advantages are described herein, and will beapparent from the following Detailed Description and the figures.

BRIEF DESCRIPTION OF THE FIGURES

FIG. 1 is a cross-section of a drug administration safety device of anembodiment of the present disclosure;

FIGS. 2A, 2B, 2C, 2D, 2E, 2F, 2G, 2H, 2I, 2J, 2K, 2L and 2M are planviews of drug administration safety devices of various embodiments ofthe present disclosure;

FIGS. 3A, 3B, 3C, 3D, 3E, 3F, 3G, 3H, 3I, 3J, 3K, 3L and 3M are planviews of drug administration safety devices of various embodiments ofthe present disclosure;

FIGS. 4A, 4B, and 4C are perspective views of an embodiment of the labelof the drug administration safety device affixed to a syringe, eachfigure having the syringe oriented in a different position;

FIG. 4D is a perspective view of an alternative embodiment of the labelof the drug administration safety device affixed to a syringe;

FIG. 5 is a perspective view of embodiments of the labels of the drugadministration safety devices affixed to syringes in place on athree-port stopcock manifold;

FIG. 6 is a perspective view of an embodiment of the label of the drugadministration safety device affixed to a syringe in use by a user; and

FIG. 7 is a plan view of a scheme for differentiating information ondrug administration safety devices.

FIG. 8 is a plan view of a drug administration safety device of anembodiment of the present disclosure;

FIG. 9 is a plan view of a drug administration safety device of anembodiment of the present disclosure;

FIG. 10 is a plan view of a drug administration safety device of anembodiment of the present disclosure;

FIG. 11 is a plan view of a drug administration safety device of anembodiment of the present disclosure;

FIG. 12 is a plan view of a drug administration safety device of anembodiment of the present disclosure;

FIG. 13 is a plan view of a drug administration safety device of anembodiment of the present disclosure;

FIG. 14 is a plan view of a drug administration safety device of anembodiment of the present disclosure;

FIG. 15 is a plan view of a drug administration safety device of anembodiment of the present disclosure;

FIG. 16 is a plan view of a drug administration safety device of anembodiment of the present disclosure;

FIG. 17 is a plan view of a drug administration safety device of anembodiment of the present disclosure;

FIG. 18 is a plan view of a drug administration safety device of anembodiment of the present disclosure;

FIG. 19 is a plan view of a drug administration safety device of anembodiment of the present disclosure;

FIG. 20 is a plan view of a drug administration safety device of anembodiment of the present disclosure;

FIG. 21 is a plan view of a drug administration safety device of anembodiment of the present disclosure;

FIG. 22 is a plan view of a drug administration safety device of anembodiment of the present disclosure;

FIG. 23 is a plan view of a drug administration safety device of anembodiment of the present disclosure;

FIG. 24 is a plan view of a drug administration safety device of anembodiment of the present disclosure;

FIG. 25 is a plan view of a drug administration safety device of anembodiment of the present disclosure;

FIG. 26 is a plan view of a drug administration safety device of anembodiment of the present disclosure;

FIG. 27 is a plan view of a drug administration safety device of anembodiment of the present disclosure;

FIG. 28 is a plan view of a drug administration safety device of anembodiment of the present disclosure;

FIG. 29 is a plan view of a drug administration safety device of anembodiment of the present disclosure;

FIG. 30 is a plan view of a drug administration safety device of anembodiment of the present disclosure;

FIG. 31 is a plan view of a drug administration safety device of anembodiment of the present disclosure;

FIG. 32 is a plan view of a drug administration safety device of anembodiment of the present disclosure;

FIG. 33 is a plan view of a drug administration safety device of anembodiment of the present disclosure;

FIG. 34 is a plan view of a drug administration safety device of anembodiment of the present disclosure;

FIG. 35 is a plan view of a drug administration safety device of anembodiment of the present disclosure;

FIG. 36 is a plan view of a drug administration safety device of anembodiment of the present disclosure;

FIG. 37 is a plan view of a drug administration safety device of anembodiment of the present disclosure;

FIG. 38 is a plan view of a drug administration safety device of anembodiment of the present disclosure;

FIG. 39 is a plan view of a drug administration safety device of anembodiment of the present disclosure;

FIG. 40 is a plan view of a drug administration safety device of anembodiment of the present disclosure;

FIG. 41 is a plan view of a drug administration safety device of anembodiment of the present disclosure;

FIG. 42 is a plan view of a drug administration safety device of anembodiment of the present disclosure; and

FIG. 43 is a plan view of a drug administration safety device of anembodiment of the present disclosure.

DETAILED DESCRIPTION

The present disclosure relates in general to apparatus and methods formaking drug delivery devices or containers safer. The present disclosuredescribes various embodiments of drug administration safety devices fora drug delivery device or drug container such as a syringe orintravenous bag, and methods of clearly enabling users to readilydifferentiate different drug containers having different drugs ordifferent concentrations of drugs in fast and reliable manner tominimize the chances of drug administration errors and potential harm topatients resulting therefrom.

Referring now to the Figures, FIG. 1, FIGS. 2A, 4A, 4B, 4C, and 5illustrate one embodiment of the drug administration safety device ofthe present disclosure, generally indicated by numeral 10 a. The drugadministration safety device 10 a includes a rectangular label 12 aconfigured to be attached to a drug container such as a syringe (i.e.,wrapped around the syringe). For example, FIGS. 4A, 4B and 4C show label12 a removed from the backing 16 and positioned on a syringe 40. Thedrug administration safety device 10 a also includes an adhesive 14 onthe back face of the label 12 a, and a backing or substrate 16 forholding the label and protecting the adhesive prior to the applicationof the label 12 a to the drug container.

The label 12 a includes a first drug name section 20 a in a firstorientation, a second drug name section 22 a in a second orientation, athird drug name section 24 a in a third orientation, a drugconcentration section 26 a, a variable information section 28 a, agraduation viewing section 30 a and a trade dress section 32 a. Thefirst orientation, second orientation, and third orientation aredifferent from each other to enable the information displayed to a userin such section (such as the name and the drug dose of the drug, etc.)to be upright, regardless of the position and orientation of the drugcontainer as further discussed below.

The first drug name section 20 a of the label 12 a is substantiallyrectangular in shape and is positioned along a horizontal orsubstantially horizontal axis in the upper left-hand corner of the label12 a. When affixed to a syringe 40 as illustrated in FIGS. 4A and 4B,the first drug name section 20 a is aligned with and oriented toward theport end 42 of the syringe 40. The first drug name section 20 a includesa prominent display of the name of the drug. The color of the first drugname section corresponds to the color code established by the ASTM forthat drug.

The second drug name section 22 a includes the name of the drug repeatedside-by-side along the section. The second drug name section 22 a ispositioned along the right side of the label 12 a along a vertical orsubstantially vertical axis and extends transverse to or perpendicularto the orientation of the first drug name section 20 a. As illustratedin FIGS. 4A, 4B, 4C, 4D and 5, when affixed to a syringe the second drugname section 22 a is substantially aligned with and oriented along theflange 44 of the barrel of the syringe 40.

The third drug name section 24 a includes the name of the drug. The drugname is repeated side-by-side along the section. The third drug namesection 24 a is positioned adjacent to and to the right of the seconddrug name section 22 a along the right edge of the label and transverseor perpendicular to the orientation of the first drug name section 20 a.The third drug name section 24 a, however, is configured in an oppositeor inverted orientation to the second drug name section 22 a such thatthe drug name is the mirror image of the drug name in drug name section22 a in this embodiment. As illustrated in FIGS. 4A, 4B, 4C, 4D and 5,when affixed to a syringe, the third drug name section 24 a issubstantially aligned with and oriented toward the flange 44 of thebarrel of the syringe 40.

Opposing orientations of the second drug name section 22 a and the thirddrug name section 24 a enables the name of the drug to be displayed inan upright position in two different orientations of the syringe (i.e.,in each respective section, the letters of the drug or other informationare positioned in an upright fashion with respect to that section) Asillustrated in FIG. 4B, the name of the drug, “Midazolam,” is orientedin an upright position in second drug name section 22 a (relative tothat section) when the needle port 42 of the syringe 40 is pointed in anupward direction. As illustrated in FIG. 4C, the name of the drug,“Midazolam,” is oriented in an upright position in the third drug namesection 24 a (relative to that section) when the needle port of thesyringe is pointed in a downward direction.

In the illustrated embodiment, the drug concentration section 26 aincludes the concentration or dosage strength of the drug, total amountof the drug in the device or container, the volume and type of thecontainer, storage information, warning statements regarding the use ofthe contents and other information regarding the contents of the drugcontainer.

In this illustrated embodiment, the variable information section 28 a ofthe label is rectangular-shaped and is positioned immediately adjacentto and below the drug concentration section 26 a of the label. Thevariable information section 28 a is substantially white in color and(although not illustrated) includes information that varies amongdifferent drug administration safety devices for the same drug andconcentration and volume of drug. Information displayed in this section28 a may, for example, include a bar code, lot number, expiration dateof the drug, national drug code (NDC) number, size and type of thedevice or container, service code, the date the formulation was made,recipient information and any other suitable information. The variableinformation section 28 a also includes information related to themanufacturer of the drug administration safety device, such as companyname, company contact information, corporate dress and any othersuitable information.

The graduation viewing section 30 a is configured to reveal certainportions of the device or container that have information displayed onor affixed to the surface of the device or container itself. Thegraduation viewing section 30 a is L-shaped forming the lower edge ofthe label 12 a and dividing the first drug name section 20 a,concentration section 26 a and the variable information section 28 afrom the second drug name section 22 a. As illustrated in FIGS. 4A and6, when the label 12 a is affixed to a syringe, the graduation viewingsection 30 a of the label 12 a of the present disclosure reveals thegraduation markings 46 on the syringe 40 as illustrated in FIG. 4A.

The trade name section 32 a is positioned adjacent to and aligned withthe third drug name section 24 a and forms the right edge of the label12 a. When affixed to a syringe as illustrated in FIGS. 4A, 4B, 4C, 4Dand 5, the trade name section 32 a is substantially aligned along andoriented toward the flange 44 of the barrel of the syringe 40. The tradename section 32 a includes the company name and trademark corporatedress.

It should be appreciated that each drug administration safety device ofthe present invention may be manufactured individually or in groups.More specifically, in one embodiment each label, adhesive and backing ismade as an individual device. In another embodiment, a plurality of drugadministration safety devices are made together in that they share thesame backing. These can be made in a roll for ease of storage and use orapplication to drug containers.

The label may be made of any suitable material and weight or thickness.The label includes a material suitable for reproduction of graphics andlettering onto its surface through any suitable printing processincluding mechanical, electronic such as electrostatic, magnetographic,ion or electron deposition, ink-jet printing, or any other suitable typeof printing process. At least a portion of the label 12 a includes amaterial that is resistant to moisture. In one embodiment, the label isa plastic. At least a portion of the label 12 a includes a syntheticplastic material such as a biaxially oriented polypropylene. The label12 a of the illustrated embodiment is substantially clear ortransparent. It should be appreciated, however, that at least a portionof the label may be opaque and include any suitable color.

The material of the label may be made at any weight or thicknesssuitable for manipulating the label to be affixed in a suitable mannerto the surface of the drug container and durable for use of the drugcontainer. In an embodiment, the thickness of the substrate is at leastabout 0.2 to about 5 mil or about 1 to about 3 mil. The thickness of thesubstrate 12 a of the drug administration safety device is about 2 mil.

It should be appreciated that the features described above are includedin each of the embodiments of the drug administration safety deviceillustrated in FIGS. 2B, 2C, 2G, 2K, and 2M.

Referring to FIGS. 2D, 2E, 2F, 2H, 2I, 2J and 2L, in an embodiment, oneor more different shapes, combination of shapes or positioning of shapesare associated with a specific drug concentration of the same drug. Inaddition to the features described above, the embodiments of the drugadministration safety device illustrated in FIGS. 2D, 2E, 2F, 2H, 2I, 2Jand 2L include one or more shapes displayed in their respective drugconcentration sections 26 d, 26 e, 26 f, 26 h, 26 i, 26 j and 26I todifferentiate different concentrations of the same drug.

For example, FIG. 5 illustrates three labels 12 h, 12 i and 12 j,illustrated in FIGS. 2H, 2I and 2J, respectively, operatively affixed tothree respective syringes 40 h, 40 i and 40 j each secured to three-portstopcock manifold 46. Although the drug name of each label is the same,the concentration of the drug is different for each syringe. Inparticular, the label 12 h on syringe 40 h includes a concentration of“100 mcg per mL,” the label 12 i on syringe 40 i includes aconcentration of “80 mcg per mL” and the label 12 j on syringe 40 jincludes a concentration of “40 mcg per mL,” respectively. In theillustrated embodiment, the different concentrations of Phenylephrineare distinguished from one another by one or more shapes or pattern ofshapes associated with the concentration information of the label. Label12 h includes a combination of triangles and a rectangle todifferentiate the concentration of syringe 40 h from the concentrationsof the other syringes 40 i and 40 j. Label 12 i includes a combinationof two squares on either side of the concentration of syringe 40 i todistinguish the concentration from the concentrations of syringes 40 hand 40 j. Label 12 j includes a rectangle outlining the concentration ofsyringe 40 j to distinguish the concentration from the concentrations ofsyringes 40 h and 40 i. It should be appreciated that the absence orpresence of one or more different shapes, combination of shapes orpositioning of shapes associated with a specific drug concentration ofthe same drug enables a user of the drug container to distinguishbetween different concentrations of the same drug within similarcontainers.

Referring now to FIGS. 3A and 4D, in a further embodiment of the drugadministration safety device of the present disclosure, generallyindicated by numeral 100 a, in addition to a first drug name section 120a, a second drug name section 122 a and a third drug name section 124 aas described above, the label 112 a includes a fourth drug name section134 a. The fourth orientation of the fourth drug name section 134 a isdifferent from the first orientation of the first drug name section 120a, a second orientation of the second drug name section 122 a and athird orientation of the third drug name section 124 a. Each of theletters in the name of the drug displayed in the fourth drug namesection 134 a of the label are positioned one on top of the other andaligned along the graduation viewing section 134 a. When the label 112 ais removed from its backing 16 and placed on a drug container such as asyringe 140, the user is able to view both the graduation markings andthe drug name when operating the syringe. This embodiment also includesa drug concentration section 126 a and a variable information section128 a and a trade name section 132 a.

It should be appreciated that the features described above are includedin each of the embodiments of the drug administration safety deviceillustrated in FIGS. 3B, 3C, 3G, 3K, and 3L except that no shape is usedin the respective drug concentration sections. It should be furtherappreciated that the features described above are included in each ofthe embodiments of the drug administration safety device illustrated inFIGS. 3D, 3E, 3F, 3H, 3I, 3J and 3M except that different shapes areused in their respective drug concentration sections 126 d, 126 e, 126f, 126 h, 126 i, 126 j and 126 m to differentiate differentconcentrations of the same drug.

FIG. 6 illustrates an example of one of the disclosed embodimentsattached to a syringe in use by a user. As illustrated in FIGS. 4A, 4B,4C, 4D and 6, the features of the disclosed embodiments combine toenable the user to view the name of the drug in virtually anyorientation of the syringe while maintaining the view of markings on thesyringe and not interfering with the function of the syringe.

It should be appreciated that the label of the drug administrationsafety device may be other suitable sizes and shapes. It should also beappreciated that the sections may be dimensioned and oriented in othersuitable manners in relation to one another and in relation to thedevice or container. Although the sections including the drug name arepositioned on the label in different orientations, it should beappreciated that other information may be displayed in differentorientations. In addition, in an alternative embodiment, one or more ofthe sections of the label of the drug administration safety device maybe affixed to the device or container as separate sections that arepositioned on the same device or container as described herein.

It should also be appreciated that information displayed in the sectionsof the label may include identification information, informationdescribing the contents of the device or any other suitable informationinforming a user how to use the contents of the device or container. Theinformation may be presented on the label in any suitable form oflettering, numbering, symbols, graphics and combinations thereof in anysuitable color or shade or any other suitable form of conveyinginformation to the user. In various embodiments, “tall-man” lettering isemployed to emphasize certain distinguishing portions of the drug name.For example, in FIGS. 2H, 2I and 2J, the first six letters of the drugname morphine (“PHENYL”) are displayed in all caps to distinguish thedrug name from other drugs ending in “-ephrine” such as “Epinephrine.”

In an alternative embodiment, the drug administration safety deviceincludes a label configured to be placed on an IV bag or container. Thelabel of the drug administration safety device of one such embodimentmay be a paper face stock which may be coated for thermal resinacceptance. It should be appreciated that the drug administration safetydevice may include any suitable mechanism of affixing the drugadministration safety device to a drug delivery device or container.

Referring now to FIG. 7, the present disclosure provides systems andmethods of differentiating information on drug administration safetydevices having similar information. In an embodiment, a scheme ofshapes, colors and shades of shapes is developed for differentconcentrations of the same drug contained in a plurality of devices orcontainers. Each dose of the same drug is associated with a differentshape or reverse printing within the shape. For example, the shape mayinclude a color that contrasts with the color of the informationassociated with the shape such as white lettering in a black shape. Theshape corresponding to the dose of the drug is displayed in the drugconcentration section of the label for that drug.

FIG. 7 illustrates a labeling scheme for distinguishing betweendifferent doses for each of the drugs, Bupivacaine, Ropivacaine andFentanyl. As illustrated in FIG. 7, a series of shapes and shapes withreverse printing is used to distinguish different concentrations of thesame drug. It should be appreciated that one dose may distinguished fromthe other doses by not having any shape associated with the dose.

The labeling scheme 210 for the drug Bupivacaine for example includes adifferent shape or shape with reverse printing for each of ninedifferent doses from “0.04,” to “0.375”. For each dose either no shapeor a different shape or reverse printing within the shape is used todistinguish each different concentration. According to the schemeillustrated in FIG. 6 a dose of “0.04” does not appear within a shape; adose of “0.0625” appears within a rectangle, a dose of “0.075” appearswithin a parallelogram; a dose of “0.1” appears within an ellipse; adose of “0.125” appears within a triangle; a dose of “0.15” appearswithin an oval in reverse printing, a dose of “0.2” appears within arectangle in reverse printing, a dose of “0.25” appears within aparallelogram in reverse printing and a dose of “0.375” appears within atriangle in reverse printing.

The scheme illustrated in FIG. 7 also includes the same scheme orsequence of shapes for increasing concentrations or doses of otherdrugs. In other words, the sequence of no shape, rectangle,parallelogram, ellipse, triangle, ellipse of reverse printing, rectanglewith reverse printing, parallelogram with reverse printing and trianglewith reverse printing for increasing doses of Bupivacaine may be thesame sequence for increasing doses of other drugs. As illustrated inFIG. 7, the labeling scheme for Bupivacaine 210 is also used fordifferent doses of Fentanyl-Bupivacaine. Alternatively, the sequence ofshapes may be different for increasing doses of each drug such as forthe Ropivacaine scheme 220 and Fentanyl scheme 230 illustrated in FIG.7.

It should be appreciated that any suitable shapes, shading within theshapes, patterns of shapes, positions of the shapes in relation toinformation and or combinations thereof may be included in a labelingscheme for a particular drug to distinguish different doses of thatdrug.

Referring now to FIGS. 8 through 42, in other embodiments, the drugadministration safety device includes a label configured to be placed onany suitable surface of a drug storage or delivery device or containersuch as an IV bag, a cassette, a drug vial, syringe, or any other deviceor container containing an agent or drug. In an embodiment, the labelincludes any feature or combination of features disclosed herein. Forexample, as illustrated in FIG. 8, the label information on label 310may include one or more drug name sections 312, drug concentrationsections 314 and 314 b, variable information sections 316 a, 316 b, 316c, 316 d, 316 e and 316 f, manufacturer, trademark and branding sections318 a and 318 b and warning statement sections 320 a and 320 b in one ormore orientations.

As illustrated, shapes are used to distinguish between differentinformation presented on the label, such as names of drugs and doses ofdrugs. As illustrated in FIG. 8, for example, in an embodiment, thelabel information is situated within a shape. It should be appreciatedthat in one embodiment the label information within the shape is inreverse printing. The drug information situated in shape 330 may be thedrug concentration as illustrated in the embodiment of FIG. 8, the drugname, as illustrated in the embodiment of FIG. 11 or both as illustratedin FIG. 12.

In an embodiment, the drug name and drug dose are situated within twodifferent shapes. For example, as illustrated in FIG. 10, the drug nameis situated within an oval shape 332 and the drug concentration issituated in a rectangle shape 334. In alternative embodiments, theshapes are placed adjacent to the label information such as shapes 336 aand 336 b adjacent to the drug name as illustrated in FIGS. 13, 14 and15.

In an embodiment, different portions of label information are situatedwithin one or more shapes. For example, as illustrated in FIG. 26, theconcentration of Oxytocin, “20 units per 500 ml” is situated within arectangle shape 338 having rounded corners. Within the rectangle shape,the dose of “20 units” is further situated inside a second rectangleshape 340. It should be appreciated that the plurality of shapes may bethe same or different. Further examples include, but are not limited to,the embodiments illustrated in FIGS. 16, 17, 19, 23 and 24.

In various embodiments, the configuration of the shapes with respect tothe label information is different for different doses of the same drug,different variations of the similar drug names or any other distinctionin the label that is advantageous and desirable to make.

In various embodiments, the label information includes one or morewarning statements such as “Verify Drug”, “IV Use Only” and “EpiduralUse Only”. In an embodiment, the warning statement is situated within ashape. For example, as illustrated in FIGS. 8 and 9, the warningstatement “Verify Drug” is situated within an octagon or a stop sign342, indicating that the user should “stop” and read the warningstatement. Also, in FIGS. 8 to 15, the warning statement, “IV Use Only”,is situated within one or more shapes such as rectangles 344 tohighlight the statement. The shapes are filled with a particular shadeor color in various embodiments and include an outline of the shape inthe same or different shade or color. For example, as illustrated inFIGS. 8 and 9, the stop-sign shape 342 including the warning statement“Verify Drug” may include the color red. Also, in FIGS. 16 to 19, theinner rectangle 344 including the warning statement, “Epidural UseOnly”, includes the color red, and the outer rectangle 346 includes thecolor yellow surrounded by a black box.

In an embodiment, the warning statements are positioned on the label togain the attention of the user such as directly above or adjacent to thedrug name. For example, in FIGS. 8 and 9, the stop sign is prominentlysituated adjacent to the drug name in the middle of the label. In FIGS.8 to 15, the warning statement “IV Use Only” is prominently situated inthe upper right-hand corner of the label so as to be visible in the samevertical plane as the drug name.

In an embodiment, at least one highlighting technique, including shapes,colors, positions and configurations, are uniform for each warningstatement. In an embodiment, warning statements, and, in particular,warning statements indicating a particular route of administration, suchas “IV Use Only” and “Epidural Use Only” are positioned in the sameposition on each label for each route of administration. For example,each label illustrated in FIGS. 8 to 15, each with different labelinformation, includes the warning statement, “IV Use Only”, situated inthe upper right-hand corner of each label. Each label illustrated inFIGS. 16 to 19, each with different label information, includes, thewarning statement, “Epidural Use Only”, situated at the top of eachlabel.

It should be appreciated that the configuration of label information andsize and shape of the labels in different embodiments are configured forthe particular drug delivery device with which the label is used. In anembodiment, each label for a particular type of drug delivery deviceincludes at least one common shape, color, position and configuration ofthe label information. For example, in an embodiment, each of theexemplary embodiments illustrated in FIGS. 20 to 22 are configured to beplaced on IV PCA (Patient Controlled Analgesia) bags, vials or drugdelivery cassettes. In a particular embodiment, the warning statement,“IV use only”, appears at the top of each label to be placed on an IVPCA bag, vial or drug delivery cassette. It should also be appreciatedthat the arrangement of label information may depend on the visibilityof certain portions of the label when the drug delivery container isplace in a drug delivery device such as a syringe in a pump.

It should be further appreciated that the label elements and informationin the illustrated embodiments are not intended to show exact wording,font styles, colors or sizes.

It should be understood that various changes and modifications to thepresently preferred embodiments described herein will be apparent tothose skilled in the art. Such changes and modifications can be madewithout departing from the spirit and scope of the present subjectmatter and without diminishing its intended advantages. It is thereforeintended that such changes and modifications be covered by the appendedclaims.

The invention is claimed as follows:
 1. A drug container labeling systemcomprising: a drug container containing a drug; a one-piece generallyrectangular label having top, bottom and side edges attached to thecontainer; and the label including a first drug name section with theletters of the name of the drug in a first orientation aligned with oneof the side edges, a second drug name section on the label with theletters of the name of the drug in a second orientation perpendicular tothe first orientation, and a third drug name section on the label withthe letters of the name of the drug in a third orientation inverted withrespect to the second orientation.
 2. The drug administration safetydevice of claim 1 in which the second drug name section is adjacent tothe third drug name section.
 3. The drug administration safety device ofclaim 1 in which the letters of the drug name in the first, second andthird sections are positioned side-by-side.
 4. The drug containerlabeling system of claim 1 in which the label includes a fourth drugname section with the letters of the name of the drug, and theorientation of the letters of the name of the drug in the fourth drugname section is different from the orientations of the letters of thename of the drug in the first, second and third drug name sections. 5.The drug container labeling system of claim 4 in which the letters ofthe name of the drug in the fourth drug name section are positioned oneabove the other.
 6. The drug administration safety device of claim 5 inwhich the letters of the name of the drug in the fourth drug namesection are oriented generally perpendicular to the letters of the nameof the drug and the second and third drug name sections.
 7. The drugcontainer labeling system of claim 1 in which the label includes a drugconcentration section with one or more of drug concentration, dosagestrength and total amount of drug in the container.
 8. The drugcontainer labeling system of claim 7 in which the concentration sectionincludes one or more shapes chosen from a sequence of different shapesassociated with different drug concentrations.
 9. The drugadministration safety device of claim 7 in which the concentrationsection includes one or more shapes, colors, or shades chosen from ascheme of shapes, colors, and shades associated with differentconcentrations of the drug.
 10. The drug container labeling system ofclaim 1 in which the label includes a variable information section withinformation chosen from the group consisting of barcodes, lot numbers,drug expiration dates, national drug code numbers, size of container,type of container, service code, date drug was formulated, recipientinformation, and information identifying the manufacturer of the drugcontainer.
 11. The drug container labeling system of claim 1 in whichthe label includes a graduation viewing section.
 12. The drug containerlabeling system of claim 11 in which the graduation viewing section isconfigured to reveal portions of the container that have graduationmarkings.
 13. The drug container labeling system of claim 11 in whichthe graduation viewing section is L-shaped.
 14. The drug containerlabeling system of claim 1 in which the label is attached to thecontainer by adhesive.
 15. The drug container labeling system of claim 1in which the container is chosen from the group consisting of an IV bag,a cassette, a drug vial, a syringe, and another container for holding adrug.
 16. The drug container labeling system of claim 1 in which thefirst drug name section is positioned along a substantially horizontalaxis of the label adjacent an edge of the label and second drug namesection is positioned along a substantially vertical axis of the labelalong an opposite edge of the label and extends transversally to theorientation of the first drug name section.
 17. The drug containerlabeling system of claim 1 in which the label is substantiallytransparent.
 18. A drug administration safety device comprising: aone-piece generally rectangular label having top, bottom and side edgesconfigured to be attached to a container for holding a drug, the labelincluding a first drug name section with the letters of the name of thedrug in a first orientation aligned with one of the side edges, a seconddrug name section on the label with the letters of the name of the drugin a second orientation perpendicular to the first orientation, and athird drug name section on the label with the letters of the name of thedrug in a third orientation inverted with respect to the secondorientation.
 19. The administration safety device of claim 18 in whichthe second drug name section is adjacent to the third drug name section.20. The drug administration safety device of claim 18 in which theletters of the drug name in the first, second and third sections arepositioned side-by-side.
 21. The drug container labeling system of claim18 in which the label includes a fourth drug name section including theletters of the name of the drug, and the orientation of the letters ofthe name of the drug in the fourth drug name section is different fromthe orientations of the letters of the name of the drug in the first,second and third drug name sections.
 22. The drug administration safetydevice of claim 18 in which the label includes a drug concentrationsection with one or more of drug concentration, dosage strength andtotal amount of drug in the container.
 23. The drug administrationsafety device of claim 22 in which the concentration section includesone or more shapes chosen from a sequence of different shapes associatedwith different drug concentrations.
 24. The drug administration safetydevice of claim 18 in which the label includes a graduation viewingsection is configured to reveal portions of the container that havegraduation markings.
 25. The drug administration safety device of claim18 in which the label is substantially transparent.
 26. A method ofreducing the risk of error in the administration of a drug from acontainer to a patient where the drug has a name including a pluralityof letters, comprising: providing a container containing the drug; andapplying a one-piece generally rectangular label having top, bottom andside edges to the container, the label including a first drug namesection with the letters of the name of the drug in a first orientationaligned with one of the side edges, a second drug name section on thelabel with the letters of the name of the drug in a second orientationperpendicular to the first orientation, and a third drug name section onthe label with the letters of the name of the drug in a thirdorientation inverted with respect to the second orientation.
 27. Themethod of reducing the risk of error in the administration of a drug ofclaim 26 in which the label includes a fourth drug name section with theletters of the name of the drug, and the orientation of the letters ofthe name of the drug in the fourth drug name section is different fromthe orientations of the letters of the name of the drug in the first,second and third drug name sections.
 28. The method of reducing the riskof error in the administration of a drug of claim 26 in which theconcentration section includes one or more shapes, colors, or shadeschosen from a scheme of shapes, colors, and shades associated withdifferent concentrations of the drug.
 29. The method of reducing therisk of error in the administration of a drug in claim 26 which thecontainer is chosen from the group consisting of an IV bag, a cassette,a drug vial, a syringe, and another container for holding a drug.